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EC number: 814-672-5 | CAS number: 109342-99-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 Apr 2018 - 17 Dec 2018
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-amino-N-[3-(diethylamino)propyl]benzamide hydrochloride
- EC Number:
- 814-672-5
- Cas Number:
- 109342-99-6
- Molecular formula:
- C14H24N3OCl
- IUPAC Name:
- 4-amino-N-[3-(diethylamino)propyl]benzamide hydrochloride
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- 4-amino-N-[3-(diethylamino)propyl]benzamid, hydrochloride, batch number: Betriebsprobe 3a + 3b, purity analysed: 96.0 % w/w.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Analytical samples taken at 0 hours (initial value) and 48 hours aged test solutions were analysed from control and all test item concentrations.
Test solutions
- Details on test solutions:
- The necessary amount of test item for preparing the stock solution S1 was weighed on a weighing scoop and transferred to a volumetric flask. Test medium (Elendt M4) was added up to the bench mark and the solution was homogenised by shaking. Afterwards the solution was clear and transparent. Lower test solutions were prepared by dilution of the appropriate solution with test medium. ~ 50 mL of the prepared solutions were transferred to each test vessel (see Table added in any other information).
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia magna Straus, Clone V, was used as the test organism. The animals are continuously bred in the laboratory and were originally purchased in a healthy condition from the Federal Environment Agency in Berlin/Germany.
Daphnia magna was bred as single culture (1 daphnid per 100 mL) in Elendt M4 medium. The pH-value of the aerated water was within a range of 6.0 – 9.0. The dissolved oxygen was above 60 % saturation and the total hardness 140 - 250 mg/L (as CaCO3), corresponding to 7.8 - 14°dH. The animals were fed with single cell green algae (Desmodesmus subspicatus, formerly Scenedesmus subspicatus) at least three times a week.
The daphnids were reared at a temperature of 20 ± 2 °C in a climatic chamber with 16 hours of illumination and 8 hours of darkness. The medium was changed three times per week. A pipette was used to separate the young daphnids from the adults.
Freshly hatched daphnids less than 24 hours old were used for the test.
Study design
- Test type:
- static
- Water media type:
- other: Elendt M4
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 13°dH (232 mg/L as CaCO3)
- Test temperature:
- 18.9 – 20.9 °C
- pH:
- 7.62 – 7.92
- Dissolved oxygen:
- ≥ 8.5 mg/L
- Salinity:
- -
- Conductivity:
- -
- Nominal and measured concentrations:
- 100, 50.0, 25.0, 12.5, 6.25 mg/L nominal
- Details on test conditions:
- Static dose-response test with twenty test organisms per treatment (4 replicates of 5 test organisms each) were used. The duration of the test was 48 hours.
The total hardness (as CaCO3) of the test medium (untreated control) was determined to be 13°dH (232 mg/L CaCO3); the mean pH-value of the untreated control was determined to be 7.70 ± 0.07 (Std. Dev.), the mean temperature of the control and all test item concentrations was measured to be 19.7 ± 0.8 °C (Std. Dev.) and the mean oxygen concentration was determined to be 8.7 ± 0.2 mg/L (Std. Dev.). - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 50 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 97.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Control immobilisation: The percentage of immobilisation should be ≤ 10 %. In this study the control immobilisation was 0 %.
Oxygen concentration: The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in all test units. In this test, the dissolved oxygen concentration at the end of the test was ≥ 8.5 mg/L.
After 24 hours of exposure no immobilisation was observed in the control and up to and including 100 mg/L.
After 48 hours of exposure no immobilisation was observed in the control and at test item concentrations 12.5 to 50.0 mg/L. No immobilisation higher than the allowed control immobilisation was observed at 6.25 mg/L. At the highest test item concentration of 100 mg/L 60 % of the daphnids were immobile.
No behavioural changes could be observed. - Results with reference substance (positive control):
- The results indicate an EC50 (24 h) of the reference item potassium dichromate between 1.00 and 2.00 mg/L. Since the results are in accordance with the requirements of the OECD guideline 202 and fall within the historical data generated with the reference item at the testing facility, the daphnids were suitable for the determination of the toxicological effects of the test item.
- Reported statistics and error estimates:
- EC50 (24h): >100
EC50 (48h): 97.8 (95 % confidence limits were not calculable)
Any other information on results incl. tables
EC50and NOEC-values of daphnids exposed to the test item evaluated using nominal concentrations
Endpoint |
4-amino-N-[3-(diethylamino)propyl]benzamid, hydrochloride[mg/L] |
|
|
24 h |
48 h |
NOEC |
100 |
50.0 |
EC50 |
> 1001) |
97.82) |
95 % confidence limit of EC50 |
- |
n.d. |
- not applicable
n.d. not determined due to mathematical reasons or inappropriate data
1)Due to an inhibition below 50% the database was weak for probit analysis which hence was not performed
2)Webull analysis using linear max. likelihood regression
Analytical Results
The initial measured content of the test item was between 88 and 99 % of nominal and the aged measured content was between 98 and 100 % of nominal. Since the content of active ingredient in the samples was between 80 and 120 % of nominal the toxicological endpoints were evaluated using nominal concentrations.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- According to the results of the test, the EC50 (48 h) was determined to be 97.8 mg/L (nominal). The corresponding NOEC (48 h) was 50.0 mg/L (nominal).
- Executive summary:
Validity criteria: Control immobilisation: The percentage of immobilisation should be ≤ 10 %. In this study the control immobilisation was 0 %.
Oxygen concentration: The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in all test units. In this test, the dissolved oxygen concentration at the end of the test was ≥ 8.5 mg/L.
Test conditions: The total hardness (as CaCO3) of the test medium (untreated control) was determined to be 13°dH (232 mg/L CaCO3); the mean pH-value of the untreated control was determined to be 7.70±0.07 (Std. Dev.), the mean temperature of the control and all test item concentrations was measured to be 19.7±0.8 °C (Std. Dev.) and the mean oxygen concentration was determined to be 8.7 ± 0.2 mg/L (Std. Dev.).
Analytical Results: The initial measured content of the test item was between 88 and 99 % of nominal and the aged measured content was between 98 and 100 % of nominal. Since the content of active ingredient in the samples was between 80 and 120 % of nominal the toxicological endpoints were evaluated using nominal concentrations.
Statistical Results: EC50and NOEC-values of daphnids exposed to the test item evaluated using nominal concentrations
4-amino-N-[3-(diethylamino)propyl]benzamid, hydrochloride [mg/L] (nominal)
24 h
48h
NOEC
100
50.0
EC50
> 1001)
97.82)
95 % confidence limit of EC50
-
n.d.
- not applicable
n.d. not determined due to mathematical reasons or inappropriate data
1)Due to an inhibition below 50% the database was weak for probit analysis which hence was not performed
2)Weibull analysis using linear max. likelihood regression
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